| | Class 2 Device Recall SafeT" PLUS Adult Lumbar Puncture Tray |  |
| Date Initiated by Firm | January 20, 2022 |
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| Create Date | March 16, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0794-2022 |
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| Recall Event ID |
89553 |
| Product Classification |
Lumbar puncture tray (adult & pediatric) - Product Code PWY
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| Product | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT |
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| Code Information |
Catalog Number: 4301CSP
Lot Numbers/UDI (GTIN, DI + PI):
0001411297 (01)10885403107771(17)220331(10)0001411297
0001412994 (01)10885403107771(17)220331(10)0001412994
0001412993 (01)10885403107771(17)220331(10)0001412993
0001413312 (01)10885403107771(17)220331(10)0001413312
0001413224 (01)10885403107771(17)220331(10)0001413224
0001415321 (01)10885403107771(17)220430(10)0001415321
0001416350 (01)10885403107771(17)220331(10)0001416350
0001416833 (01)10885403107771(17)220430(10)0001416833
0001417546 (01)10885403107771(17)220430(10)0001417546
0001418031 (01)10885403107771(17)220430(10)0001418031
0001418108 (01)10885403107771(17)220430(10)0001418108
0001418415 (01)10885403107771(17)220430(10)0001418415
0001420365 (01)10885403107771(17)220430(10)0001420365
0001421922 (01)10885403107771(17)220630(10)0001421922
0001422603 (01)10885403107771(17)220630(10)0001422603
0001422916 (01)10885403107771(17)220630(10)0001422916
0001423132 (01)10885403107771(17)220630(10)0001423132
0001424769 (01)10885403107771(17)220630(10)0001424769
0001425084 (01)10885403107771(17)220630(10)0001425084
0001426503 (01)10885403107771(17)220630(10)0001426503
0001426326 (01)10885403107771(17)220630(10)0001426326
0001427017 (01)10885403107771(17)220630(10)0001427017
0001427227 (01)10885403107771(17)220630(10)0001427227
0001427711 (01)10885403107771(17)220630(10)0001427711
0001428496 (01)10885403107771(17)220630(10)0001428496
0001429509 (01)10885403107771(17)220630(10)0001429509
0001430610 (01)10885403107771(17)220630(10)0001430610
0001430605 (01)10885403107771(17)220630(10)0001430605
0001431471 (01)10885403107771(17)220630(10)0001431471
0001432426 (01)10885403107771(17)220831(10)0001432426
0001432425 (01)10885403107771(17)220831(10)0001432425
0001433266 (01)10885403107771(17)220831(10)0001433266
0001434250 (01)10885403107771(17)220930(10)0001434250
0001437530 (01)10885403107771(17)221031(10)0001437530
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| FEI Number |
2020394
|
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
|
| For Additional Information Contact | North American Regional Complaint Center
844-823-5433 |
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Manufacturer Reason
for Recall | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
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FDA Determined
Cause 2 | Process control |
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| Action | Between 01/28 and 02/01/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via email and FedEx 2-day mailings to customers informing them that between 07/02 to 12/15/2021 the firm received 59 customer complaints for lumbar puncture tray manometers with reported failure modes of leaking and mating issues.
Customers are asked to take the following actions:
1. Check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facility s destruction process.
2. Share this notification with all users within their facilities to ensure they are also aware of this Urgent Medical Device Correction.
3. If Customers purchased this product from a distributor, contact their distributor for further instructions and credit resolution.
4. Complete and return the attached Customer Response Form to the Recalling Firm contact noted on the form confirming acknowledgement of the correction notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process their credit.
5. Indicate on the response form the quantity of affected product identified at their facility and confirm that this inventory was destroyed.
6. Contact their Recalling Firm's representative to assist in this process or they may also contact the listed in the notification for further assistance.
For further assistance contact:
North American Regional Complaint Center -
1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted
M-F 8am - 5pm CT |
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| Quantity in Commerce | 49,760 devices |
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| Distribution | U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S. (foreign) including states: Costa Rica and Hong Kong. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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